Use Case

CAPA management that closes loops, not just tickets

Root cause analysis, action tracking, and effectiveness verification — all in one system that proves to ISO and FDA auditors that your corrective actions actually work.

-60%CAPA recurrence rate
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The problem

CAPA systems that track actions without verifying effectiveness do not prevent recurrence. The loop must close with evidence that the root cause was actually addressed.

  • ×CAPAs initiated and actions assigned but effectiveness verification not systematically required
  • ×Root cause analysis quality inconsistent because the process is not guided or structured
  • ×Regulatory auditors find the same root causes repeating, proving CAPA closure was inadequate

The solution

How Certexi solves it

  • Structured CAPA workflow: input source → problem definition → RCA → action → evidence → effectiveness check
  • RCA methodology selection: 5-why, fishbone, fault tree — structured templates built into workflow
  • Effectiveness verification: define metric → collect evidence → assess improvement → close with evidence

Platform capabilities

What Certexi provides for capa management (corrective & preventive action)

CAPA initiation from any source: NCR, audit finding, customer complaint, incident
Structured root cause analysis with methodology templates
Action assignment with due date tracking and escalation
Effectiveness verification workflow with quantitative and qualitative evidence
CAPA trend analysis: source types, root cause categories, and cycle times

Sector coverage

Industries that rely on capa management (corrective & preventive action)

Manufacturing & OperationsEnergy & UtilitiesHealthcare & PharmaGovernment & Public Sector

Compliance support

Regulatory frameworks this use case supports

ISO 9001FDA 21 CFR PART 820ISO 13485IATF 16949

PRECIOS

Alineado al Valor Operativo, No al Número de Usuarios

El precio depende del alcance del despliegue, no del número de usuarios. Tus datos. Tu infraestructura. Tus reglas.

Todos los planes incluyen despliegue privado. Tu información permanece en tu infraestructura.

ISO 27001 Aligned
Private Deployment
Unlimited Users

Piloto

Valida antes de comprometerte

Personalizado

5 lugares por trimestre

  • Despliegue completo de plataforma
  • Soporte de configuración
  • Capacitación e incorporación
  • Acceso directo al equipo de producto
  • Iteración basada en retroalimentación
  • Período de evaluación de 8 semanas

Estándar

Operaciones de una ubicación

Desde $2,500

por mes, facturado anualmente

  • Todas las capacidades centrales
  • Biblioteca de plantillas estándar
  • Despliegue privado incluido
  • Soporte por email (respuesta 24h)
  • Actualizaciones trimestrales
  • Usuarios ilimitados

Enterprise

Multi-ubicación, alto cumplimiento

Personalizado

Basado en alcance del despliegue

  • Todo lo de Estándar
  • Desarrollo de plantillas personalizadas
  • Ingeniero de soporte dedicado
  • Garantías SLA
  • Integraciones avanzadas
  • Opción de despliegue air-gapped

Despliegue Privado Incluido en Todos los Planes

Cada plan incluye despliegue completo en tu infraestructura — Nextcloud, servidores Linux, Docker, Kubernetes o entornos air-gapped. Tu información nunca sale de tu control.

Every CAPA closed with evidence of effectiveness.

Start with a 30-day free trial. Private deployment included.

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